DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This Office Action is responsive to the amendment filed on 07/27/2026. As directed by the amendment: Claims 4, 7 and 11-12 have been amended, claims 1-3, 13, and 18-21 have been cancelled, and no claims have been added. Claims 22-25 were previously withdrawn due to a Restriction Requirement. Thus, claims 4-12 and 14-17 are presently under consideration in this application.
Response to Arguments
Applicant's arguments, see pages 12-15, filed 08/25/2025, for claims 4-12 and 14-17 under 35 U.S.C. 103 have been fully considered but they are not persuasive. Applicant argues on page 13 that “The Office Action further states that "[a]lthough Fig. 5 may show a vertical alignment of structure stacked over one another, this alignment is not claimed." Id. at pages 4-5. Applicant submits that the amendments to claims 4 and 11 now positively recite the stacked/overlapping relationship along the normal direction that the Examiner indicated was not previously claimed.” Applicant then asserts on page 14 that “Lee does not disclose or suggest this claimed arrangement. In Lee, the measurement electrodes (third wiring electrodes 831c, shown as element 902 in FIG. 14) are located at the distal ends of the extension portions (811b), remote from the central coupling portion (811a/911a) where the device terminals (first wiring electrodes 831a / terminals 731a-731d) are located. Lee, FIGS. 12-14. The measurement electrodes 831c are connected to the first wiring electrodes 831a only through elongated routing traces (second wiring electrodes 831b) that extend along the extension portions. Lee, paragraph [0118] ("the wiring structure may include first wiring electrodes 831a and second wiring electrodes 831b, and is capable of electrically connecting the measurement electrode(s) (e.g., a third wiring electrode 831c to be described later) to a measurement module"). Because Lee's measurement electrodes 831c are laterally displaced at the distal ends of the extension portions and connected to the device-facing terminals only by an intervening routing trace (831b), Lee's alleged measurement electrode, electrode contact, and device terminal cannot "at least partially overlap one another along a direction extending normal to the skin-facing side of the first type of attachment patch" as now required by claim 4 and cannot "at least partially overlap one another along a direction extending normal to the substrate" as now required by claim 11.” Applicant further asserts on page 15 that the Quinlan reference also does not cure the deficiency stated above.
Examiner disagrees because the amendments do not recite a stacked configuration shown in Fig. 5 of the instant application, but rather, under broadest reasonable interpretation, the phrase “at least partially overlap one another along a direction extending normal to the skin-facing side” is not a stacked/overlapped configuration, but rather, overlapping in the direction towards the skin. This means that the first/second patch electrode, first/second electrode contact, and first/second electrode of the ECG device alignment overlap one another in the direction of the skin, which the Lee reference does exactly that because the alignment of electrodes of the device (831a) to the electrode contacts (831b) and patch electrodes (831c) is a physical alignment, as each of the structures are touching one another and directed to the skin, since these structures are capable of obtaining ECG signal.
Applicant then argues on page 14 that “the Office Action's failure to give limiting effect to the "consists essentially of" phrasing in claims 4 and 11. Office Action, page 5. The first type of attachment patch as recited in claims 4 and 11 consists essentially of the listed elements- substrate, adhesive layers, patch electrodes, electrode contacts, and the common patch electromechanical interface-without any separate electrically conductive routing structure between the electrode contact and the patch electrode. Lee necessarily requires such a routing structure (second wiring electrode 831b) to carry its measurement electrode out to the distal end of the extension portion. The inclusion of such a routing structure is inconsistent with the recited first type of attachment patch, which requires the patch electrode, electrode contact, and device electrode to overlap along a direction normal to the substrate rather than be laterally displaced and connected by a trace.”
Examiner disagrees because the claim is interpreted as open-ended language because the first type attachment patch, the second type attachment patch, the common patch electromechanical interface of the first type of attachment patch , and the common patch electromechanical interface of the second type of attachment patch fails to limit the scope of the claim because the preamble recites the term “comprising” and the Applicant has failed to show how the particulars of these components materially affect the basic and novel characteristic(s) of the claimed invention. In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463. See MPEP 2111.03(III).
Applicant argues on page 15 that “Regarding the alternative rejection of claim 11 over Lee alone, the Examiner has alleged that Lee's magnets are a functional equivalent of the claimed adhesive layer. Office Action, page 24. Applicant respectfully submits that this equivalence is conclusory. Claims 4 and 11 require an adhesive layer that "defines cutouts around the electrode contacts to avoid the adhesive layer interfering with an electrical connection." A magnet performs a different coupling function and does not define cutouts around electrode contacts. Moreover, even if the magnet were considered equivalent for coupling purposes, Lee still fails to disclose the overlapping arrangement of patch electrodes, electrode contacts, and device electrodes along a direction normal to the skin-facing side of the first type of attachment patch or normal to the substrate, as discussed above.”
Examiner disagrees because the use of magnets would allow for space efficiency while also keeping the layers together, which is not a conclusory statement.
Applicant lastly argues on page 15 that “Regarding the combination of Lee with Bardy for claims 5 and 12, Bardy is directed to an insertable/implantable cardiac monitor, a different device class from a skin-worn attachment patch. Bardy, Abstract. Bardy does not cure the deficiencies of Lee as to the independent claims from which claims 5 and 12 depend. Applicant also notes that the Office Action's rationale for claims 5 and 12 refers to modifying "the ECG system of Uriel," a reference that does not appear to be of record.”.
Examiner disagrees because Bardy teaches external worn electrodes on a user to collect ECG, which is still the same field of endeavor. Furthermore, the distance between electrodes is routine optimization, as shown using Brady reference. The use of the name “Uriel” was inadvertent and should be Lee as noted in the header. Therefore, the rejection of record is maintained. See updated rejection below.
Claim Objections
Claim 7 is objected to because of the following informalities: the phrase “two second patch electrodes” is recited in claim 4 and should be amended to recite “the two second patch electrodes”. Appropriate correction is required.
Claim Interpretation
Regarding claims 4, and 11, the recitation of the phrase “consists essentially of” will be interpreted as open-ended language because the first type attachment patch, the second type attachment patch, the common patch electromechanical interface of the first type of attachment patch , and the common patch electromechanical interface of the second type of attachment patch fails to limit the scope of the claim because the preamble recites the term “comprising” and the Applicant has failed to show how the particulars of these components materially affect the basic and novel characteristic(s) of the claimed invention. In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463. See MPEP 2111.03(III).
Regarding claim 11, the first adhesive layer is interpreted to be separate component than the substrate because the phrase “the first adhesive layer configured to be positioned between and in direct contact with the ECG device and the substrate” can allow for the interpretation of a separate component or a layer on the substrate itself, so long that the first adhesive layer is between and touching substrate and ECG device. The second adhesive will be interpreted as part of the substrate.
Regarding claims 4 and 11, the partial alignment of the device electrode and the electrode contact with the patch electrode for the first and second electrodes of the device and patches can be interpreted as an physical and electrical alignment in which the device electrode, the electrode contact and the patch electrode must electrically align to be capable of obtaining ECG. If Applicant is trying to claim the alignment of Fig. 5, Applicant must structurally describe the alignment disclosed.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 11, and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US 20190239769)(Hereinafter Lee) in view of Quinlan et al. (US 20160242654)(Hereinafter Quinlan).
Regarding claim 11, Lee teaches An electrocardiogram (ECG) system (Fig. 3 (300)), comprising:
an ECG device that includes a housing, an ECG sensor disposed in the housing, and first and second electrodes accessible from outside the housing and electrically coupled to the ECG sensor, wherein the housing and the first and second electrodes define an ECG device electromechanical interface (Fig. 8 (600 measurement module/ECG device, 601 housing, 631a-d electrodes accessible outside the housing) [0099] “an electronic device (e.g., a processor (e.g., processor 120 of FIG. 1) of the measurement module 600) may identify an input or request associated with an electrocardiogram [since ECG is collected via electrodes, it contains an ECG sensor] measurement of a living body”);
a first type of attachment patch that includes a common patch electromechanical interface that is complementary to the ECG device electromechanical interface and two first patch electrodes with a first spacing (Fig. 14 Pad of col. 4 row 2. See first patch electrodes 902 that are circles on the ending of each curve. The common patch electromechanical interface is 911a that contains the electrodes on the pad of Fig. 13 that attaches the ECG device to the pad. See the spacing between the electrodes visually in Fig. 14. [0124] “there may be various extension directions or lengths of the extension portions (e.g., the extension portions 811b in FIG. 13).”); and
a second type of attachment patch that includes the common patch electromechanical interface that is complementary to the ECG device electromechanical interface and two second patch electrodes with a second spacing that is greater than the first spacing (Fig. 14 Pad of col. 3 row 2. See second patch electrodes 902 that are circles on the ending of each curve. The common patch electromechanical interface is 911a that contains the electrodes on the pad of Fig. 13 that attaches the ECG device to the pad. The position of electrodes 902 between the second and first type pads can be visually seen as the distance between the electrodes 902 of col. row 2 is far greater than the spacing of col. 4 row 2),
wherein the first type of attachment patch consists essentially of:
a substrate (Fig. 3(302));
the two first patch electrodes on a skin-facing side of the substrate (See first patch electrodes 902.);
two first electrode contacts partially embedded in the substrate and each having an exposed device-facing side at least partially aligned for electrical coupling to a corresponding one of the first and second electrodes of the ECG device ([0106] “As will be described later, the first to fourth terminals 731a to 731d [ECG device electrodes 431a-d are electrically coupled to 731a-d [0109]-[0110]] may be electrically connected to a first wiring electrode (e.g., the first wiring electrode 831a [first electrode contacts] in FIG. 12) disposed substantially in the pad body, or may be a part of the first wiring electrode.” The ECG device electrodes must be aligned with the electrode contacts for electrical coupling as the device cannot function without alignment, see Fig. 3.), wherein a first patch electrode of the two first patch electrodes and a first electrode contact of the two first electrode contacts is configured to at least partially align with the first electrode of the ECG device such that the first patch electrode, the first electrode contact, and the first electrode of the ECG device at least partially overlap one another along a direction extending normal to the substrate and a second patch electrode of the two first patch electrodes and a second electrode contact of the two first electrode contacts is configured to at least partially align with the second electrode of the ECG device such that the second patch electrode, the second electrode contact, and the second electrode of the ECG device at least partially overlap one another along the direction extending normal to the substrate (See Fig. 12 where device electrodes 831a are aligned with electrode traces 831, which are aligned with patch electrodes 831c. The alignment is a physical alignment with one another and an electrical alignment to be capable of collecting ECG. The first and second patch electrodes (831c), electrode contacts (831a), and electrode on the ECG devices (631a-d) overlap one another in the direction of the skin (thereby to both the substrate and the skin facing side of the first type of attachment patch/substrate) to be able to collect the ECG. This direction is simply the electrical connection between the skin to the ECG device electrode, via the patch electrodes and contact electrodes. It is further noted that the claim is not claiming a direct vertical, over the top, configuration of the 3 components.);
a first adhesive layer on a device-facing side of the substrate, ([0111] “In another embodiment, the second adhesive member 721 may be provided on a first face of the pad body (e.g., the first face F1 in FIG. 13) rather than on the seating plate 711” Examiner notes that the claim recites that there is an adhesive layer on the backing material that is facing the device, and it is unclear how the adhesive layer is included in the common patch electromechanical interface. It is noted the claim does not limit the adhesive layer to be touching the common patch electromechanical interface, but only needs to be touch the pad/backing. See Fig. 13 where adhesive 821 takes shape of the common patch electromechanical interface of Fig. 7’s housing.), wherein the first adhesive layer defines two first cutouts around the two first electrode contacts to avoid the first adhesive layer interfering with an electrical connection between the two first electrode contacts of the first type of attachment patch and the first and second electrodes of the ECG device (See Fig. 9 (721) that show the adhesive that contains cutouts for the electrodes. See MPEP 2114(I) regarding functional language. Since the structure of an adhesive containing cutouts is taught, the functional language, of avoiding layer interference, is possessed in the structure. ),
a second adhesive layer on a skin-facing side of the substrate, wherein the second adhesive layer defines two second cutouts around the two first patch electrodes to avoid the second adhesive layer interfering with an electrical connection between the two first patch electrodes of the first type of attachment patch and skin of a subject ([0121] “when the second adhesive layer 801c [second adhesive layer] is attached to the user's body (skin), the third wiring electrode(s) 831c may be in direct contact with the user's body.” See MPEP 2114(I) regarding functional language. Since the structure of an adhesive containing cutouts is taught, the functional language, of avoiding layer interference, is possessed in the structure.); and
the common patch electromechanical interface of the first type of attachment patch that consists essentially of a portion of the substrate to which the ECG device is couplable, the first adhesive layer configured to couple the portion of the substrate to the ECG device, and the two first electrode contacts (Fig. 14 Pad of col. 4 row 2. See first patch electrodes 902 that are circles on the ending of each curve. The common patch electromechanical interface is 911a that contains the electrodes on the pad of Fig. 13 that attaches the ECG device to the pad. See the spacing between the electrodes visually in Fig. 14. See Fig. 12 with the attachment of first adhesive 821 to the substrate of the first type patch 801, which 721 (equivalent to 821) of Fig. 9 shows attachment to the housing of the ECG device of Fig. 3.).
Lee teaches different embodiments of the adhesive location ([0111]) and different types of attachment patches (Fig. 14). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to combine the embodiments of the adhesive location ([0111]) and different types of attachment patches (Fig. 14) of Lee because such a modification would to allow for the different uses of the pads for an improvement in the flexibility of the attachment pad (0125).
However, Lee does not teach the adhesive layer configured to be positioned between and in direct contact with the ECG device and the backing material. Quinlan, in the same field of endeavor, teaches reusable electrodes on a physiological monitoring device to be worn on a patch (Abstract), similar to the device of Lee, and further teaches the adhesive layer configured to be positioned between and in direct contact with the ECG device and the backing material ([0032] “a replaceable electrode strip 150 may be adhered, temporarily, to a lower surface of a health-monitor patch 100, as depicted in FIG. 1B.” Although not explicitly an adhesion layer like 152, Examiner notes that the adhesion between the electrode strip and the patch 100 must be an adhesion layer since they are connected, as seen in Fig. 1B. ) to temporarily adhere the surface, allowing for a reusable electrode strip ([0032]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the adhesive electrode patch of Lee, with the adhesive layer configured to be positioned between and in direct contact with the ECG device and the backing material of Quinlan, because such a modification would allow to temporarily adhere the surface, allowing for a reusable electrode strip.
Regarding claim 14, Lee teaches wherein:
the second type of attachment patch further comprises third and fourth electrode contacts in the second type of attachment patch that are exposed at a device-facing side of the second type of attachment patch and that are configured to align with and electrically couple to the first and second electrodes of the ECG device ([0106] “As will be described later, the first to fourth terminals 731a to 731d [ECG device electrodes 431a-d are electrically coupled to 731a-d [0109]-[0110]] may be electrically connected to a first wiring electrode (e.g., the first wiring electrode 831a [second electrode contacts] in FIG. 12) disposed substantially in the pad body, or may be a part of the first wiring electrode.” The ECG device electrodes must be aligned with the electrode contacts for electrical coupling as the device cannot function without alignment, see Fig. 3. Examiner notes that the patches of Fig. 14 contain different electrode contacts than one another, as each patch is different than one another. The third and fourth electrode contacts are a part of the different patches, as noted by the described patch’s first and second electrode contacts.);
the two second patch electrodes comprise first and second patch electrodes with the second spacing in the second type of attachment patch that are exposed at a skin-facing side of the second type of attachment patch opposite the device-facing side (Fig. 14 Pad of col. 3 row 2. See second patch electrodes 902 that are circles on the ending of each curve. The common patch electromechanical interface is 911a that contains the electrodes on the pad of Fig. 13 that attaches the ECG device to the pad. The position of electrodes 902 between the second and first type pads can be visually seen as the distance between the electrodes 902 of col. row 2 is far greater than the spacing of col. 4 row 2.); and
the second type of attachment patch further comprises:
a first electrically conductive structure in the second type of attachment patch that electrically couples the first electrode contact to the first patch electrode ([0118] “the wiring structure may include first wiring electrodes 831a [second electrode contacts] and second wiring electrodes 831b [electrically conductive structures], and is capable of electrically connecting the measurement electrode(s) (e.g., a third wiring electrode 831c [second patch electrodes] to be described later) to a measurement module (e.g., the measurement module 400 in FIG. 5).”); and
a second electrically conductive structure in the second type of attachment patch that electrically couples the second electrode contact to the second patch electrode ([0118] “the wiring structure may include first wiring electrodes 831a [second electrode contacts] and second wiring electrodes 831b [electrically conductive structures], and is capable of electrically connecting the measurement electrode(s) (e.g., a third wiring electrode 831c [second patch electrodes] to be described later) to a measurement module (e.g., the measurement module 400 in FIG. 5).”).
Regarding claim 15, Lee teaches wherein each of the first and second electrically conductive structures comprises one or more electrical traces, one or more wires, one or more nanowires, or
one or more electrically conductive ink structures formed in the second type of attachment patch ([0101] “the first to fourth electrodes or the third wiring electrode 831c of FIG. 12, or to mean including a wiring path (e.g., the second wiring electrode 831b in FIG. 12) connecting the first to fourth electrodes and the third wiring electrode 831c”).
Regarding claim 16, Lee teaches wherein the ECG device electromechanical interface and the common patch electromechanical interface are configured to cooperate to electromechanically couple the ECG device to an attachment patch of the first type and an attachment patch of the second type ([0093] “the coupling structure between a measurement module and an attachment pad (e.g., the module housing 301 and the attachment pad 302 in FIG. 3)” See Fig. 14 for the different pad’s for the first and second types. Examiner also notes the term “cooperate” as unclear claim language as that seemingly requires two objects to actively work together, mainly as humans. ).
Regarding claim 17, Lee teaches wherein:
each of the first type of attachment patch and the second type of attachment patch is configured to be electrically coupled to the ECG device through the common patch electromechanical interface and the ECG device electromechanical interface and to skin of a subject through the two first or two second patch electrodes ([0093] “the coupling structure between a measurement module and an attachment pad (e.g., the module housing 301 and the attachment pad 302 in FIG. 3)” See Fig. 14 for the different pad’s for the first and second types the can all fit the same measurement housing 301.);
the first type of attachment patch includes a non-arrythmia attachment patch (Fig. 14. Examiner notes that the patch can be any electrode patch that is capable of sensing the intended signal as the construction of the patch is not described and fails to include any circuitry to sense the specific signals and further fails to include any circuitry that limits its ability to sense other types of signals. Fig. 14 can be any type of patch making it non-arrhythmia.);
the second type of attachment patch includes an arrythmia attachment patch (Fig. 14. Examiner notes that the patch can be any electrode patch that is capable of sensing the intended signal as the construction of the patch is not described and fails to include any circuitry to sense the specific signals and further fails to include any circuitry that limits its ability to sense other types of signals. Fig. 14 can be any type of patch making it arrhythmia.);
each non-arrythmia attachment patch is configured to direct electrical signals from locations of the subject at which the two first patch electrodes are positioned when the non- arrythmia attachment patch is coupled to the skin of the subject to, respectively, the first and second electrodes of the ECG device ([0121] “According to certain embodiments, when the second adhesive layer 801c is attached to the user's body (skin), the third wiring electrode(s) 831c may be in direct contact with the user's body… a biological signal may be detected by the third wiring electrode(s) 831c and may be transmitted to a measurement module (e.g., the first to fourth electrodes 431a to 431d in FIG. 5)” Of the attachments of Fig. 14 electrodes 902/831c are coupled to the skin and direct signals to the measurement device.); and
each arrythmia attachment patch is configured to direct electrical signals from locations of the subject at which the two second patch electrodes are positioned when the arrythmia attachment patch is coupled to the skin of the subject to, respectively, the first and second electrodes of the ECG device ([0121] “According to certain embodiments, when the second adhesive layer 801c is attached to the user's body (skin), the third wiring electrode(s) 831c may be in direct contact with the user's body… a biological signal may be detected by the third wiring electrode(s) 831c and may be transmitted to a measurement module (e.g., the first to fourth electrodes 431a to 431d in FIG. 5)” Of the attachments of Fig. 14 electrodes 902/831c are coupled to the skin and direct signals to the measurement device.).
Claims 4 and 6-10 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US 20190239769)(Hereinafter Lee).
Regarding claim 4, Lee teaches A manufacturing method ([0116] “manufacturing” Examiner notes that since the system has been produced, the manufacturing method can be made. ), comprising:
an ECG device that includes a housing, an ECG sensor disposed in the housing, and first and second electrodes accessible from outside the housing and electrically coupled to the ECG sensor, wherein the housing and the first and second electrodes define an ECG device electromechanical interface (Fig. 8 (600 measurement module/ECG device, 601 housing, 631a-d electrodes accessible outside the housing) [0099] “an electronic device (e.g., a processor (e.g., processor 120 of FIG. 1) of the measurement module 600) may identify an input or request associated with an electrocardiogram [since ECG is collected via electrodes, it contains an ECG sensor] measurement of a living body”);
a first type of attachment patch that includes a common patch electromechanical interface that is complementary to the ECG device electromechanical interface and two first patch electrodes on a skin-facing side of the first type of attachment patch and with a first spacing, a first patch electrode of the two first patch electrodes and a first electrode contact of two first electrode contacts of the first type of attachment patch configured to at least partially align with the first electrode of the ECG device such that the first patch electrode, the first electrode contact, and the first electrode of the ECG device at least partially overlap one another along a direction extending normal to the skin-facing side of the first type of attachment patch and a second patch electrode of the two first patch electrodes and a second electrode contact of the two first electrode contacts of the first type of attachment patch configured to at least partially align with the second electrode of the ECG device such that the second patch electrode, the second electrode contact, and the second electrode of the ECG device at least partially overlap one another along the direction extending normal to the skin-facing side of the first type of attachment patch (Fig. 14 Pad of col. 4 row 2. See first patch electrodes 902 that are circles on the ending of each curve. The common patch electromechanical interface is 911a that contains the electrodes on the pad of Fig. 13 that attaches the ECG device to the pad. See the spacing between the electrodes visually in Fig. 14. [0124] “there may be various extension directions or lengths of the extension portions (e.g., the extension portions 811b in FIG. 13).” See Fig. 12 where device electrodes 831a are aligned with electrode traces 831, which are aligned with patch electrodes 831c. The alignment is a physical alignment with one another and an electrical alignment to be capable of collecting ECG. The first and second patch electrodes (831c), electrode contacts (831a), and electrode on the ECG devices (631a-d) overlap one another in the direction of the skin (thereby to both the substrate and the skin facing side of the first type of attachment patch/substrate) to be able to collect the ECG. This direction is simply the electrical connection between the skin to the ECG device electrode, via the patch electrodes and contact electrodes. It is further noted that the claim is not claiming a direct vertical, over the top, configuration of the 3 components.),
a second type of attachment patch that includes the common patch electromechanical interface that is complementary to the ECG device electromechanical interface and two second patch electrodes with a second spacing that is greater than the first spacing (Fig. 14 Pad of col. 3 row 2. See second patch electrodes 902 that are circles on the ending of each curve. The common patch electromechanical interface is 911a that contains the electrodes on the pad of Fig. 13 that attaches the ECG device to the pad. The position of electrodes 902 between the second and first type pads can be visually seen as the distance between the electrodes 902 of col. row 2 is far greater than the spacing of col. 4 row 2);
the first type of attachment patch consists essentially of a substrate, a first adhesive layer on a device-facing side of the substrate, a second adhesive layer on a skin-facing side of the substrate, the two first patch electrodes on the skin-facing side of the substrate, the two first electrode contacts on the device-facing side of the substrate and each electrically coupled to a different one of the two first patch electrodes, and the common patch electromechanical interface (Fig. 14 Pad of col. 4 row 2. See first patch electrodes 902 that are circles on the ending of each curve. The common patch electromechanical interface is 911a that contains the electrodes on the pad of Fig. 13 that attaches the ECG device to the pad. See the spacing between the electrodes visually in Fig. 14. See Fig. 12 with the attachment of first adhesive 821 to the substrate of the first type patch 801, which 721 (equivalent to 821) of Fig. 9 shows attachment to the housing of the ECG device of Fig. 3 via electromechanical interface. See Fig. 12 for second adhesive layer 801c and two first electrode contacts 831a, where the patch and electrode contacts are electrically coupled via 831b.); and
the common patch electromechanical interface of the first type of attachment patch that consists essentially of a portion of the substrate to which the ECG device is couplable, the first adhesive layer configured to couple the portion of the substrate to the ECG device, and the two first electrode contacts (Fig. 14 Pad of col. 4 row 2. See first patch electrodes 902 that are circles on the ending of each curve. The common patch electromechanical interface is 911a that contains the electrodes on the pad of Fig. 13 that attaches the ECG device to the pad. See the spacing between the electrodes visually in Fig. 14. See Fig. 12 with the attachment of first adhesive 821 to the substrate of the first type patch 801, which 721 (equivalent to 821) of Fig. 9 shows attachment to the housing of the ECG device of Fig. 3.).
Lee teaches different embodiments of the different types of attachment patches (Fig. 14). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to combine the embodiments of the different types of attachment patches (Fig. 14) of Lee because such a modification would to allow for the different uses of the pads for an improvement in the flexibility of the attachment pad (0125).
Regarding claim 6, Lee teaches wherein the two first electrode contacts are configured to at least partially align with the first and second electrodes of the ECG device ([0106] “As will be described later, the first to fourth terminals 731a to 731d [ECG device electrodes 431a-d are electrically coupled to 731a-d [0109]-[0110]] may be electrically connected to a first wiring electrode (e.g., the first wiring electrode 831a [first electrode contacts] in FIG. 12) disposed substantially in the pad body, or may be a part of the first wiring electrode.” The ECG device electrodes must be aligned with the electrode contacts for electrical coupling as the device cannot function without alignment, see Fig. 3. [0118] “the wiring structure may include first wiring electrodes 831a [first electrode contacts] and second wiring electrodes 831b [electrically conductive structures], and is capable of electrically connecting the measurement electrode(s) (e.g., a third wiring electrode 831c [first patch electrodes] to be described later) to a measurement module (e.g., the measurement module 400 in FIG. 5).” Examiner notes that “at least partially” can mean fully.).
Regarding claim 7, Lee teaches wherein:
the second type of attachment patch further comprises third and fourth electrode contacts in the second type of attachment patch that are exposed at a device-facing side of the second type of attachment patch and that are configured to align with and electrically couple to the first and second electrodes of the ECG device ([0106] “As will be described later, the first to fourth terminals 731a to 731d [ECG device electrodes 431a-d are electrically coupled to 731a-d [0109]-[0110]] may be electrically connected to a first wiring electrode (e.g., the first wiring electrode 831a [second electrode contacts] in FIG. 12) disposed substantially in the pad body, or may be a part of the first wiring electrode.” The ECG device electrodes must be aligned with the electrode contacts for electrical coupling as the device cannot function without alignment, see Fig. 3. Examiner notes that the patches of Fig. 14 contain different electrode contacts than one another, as each patch is different than one another. The third and fourth electrode contacts are a part of the different patches, as noted by the described patch’s first and second electrode contacts.);
the two second patch electrodes comprise first and second patch electrodes with the second spacing in the second type of attachment patch that are exposed at a skin-facing side of the second type of attachment patch opposite the device-facing side of the second type of attachment patch (Fig. 14 Pad of col. 3 row 2. See second patch electrodes 902 that are circles on the ending of each curve. The common patch electromechanical interface is 911a that contains the electrodes on the pad of Fig. 13 that attaches the ECG device to the pad. The position of electrodes 902 between the second and first type pads can be visually seen as the distance between the electrodes 902 of col. row 2 is far greater than the spacing of col. 4 row 2.); and
the second type of attachment patch further comprises:
a first electrically conductive structure in the second type of attachment patch that electrically couples the third electrode contact to one of the two second patch electrodes ([0118] “the wiring structure may include first wiring electrodes 831a [third electrode contacts, which Examiner notes that the patches of Fig. 14 contain different electrode contacts than one another, as each patch is different than one another requiring a different electrode contact.] and second wiring electrodes 831b [electrically conductive structures], and is capable of electrically connecting the measurement electrode(s) (e.g., a third wiring electrode 831c [second patch electrodes] to be described later) to a measurement module (e.g., the measurement module 400 in FIG. 5).”); and
a second electrically conductive structure in the second type of attachment patch that electrically couples the fourth electrode contact to a different one of the two second patch electrodes ([0118] “the wiring structure may include first wiring electrodes 831a [fourth electrode contacts, which Examiner notes that the patches of Fig. 14 contain different electrode contacts than one another, as each patch is different than one another requiring a different electrode contact.] and second wiring electrodes 831b [electrically conductive structures], and is capable of electrically connecting the measurement electrode(s) (e.g., a third wiring electrode 831c [second patch electrodes] to be described later) to a measurement module (e.g., the measurement module 400 in FIG. 5).”).
Regarding claim 8, Lee teaches wherein each of the first and second electrically conductive structures comprises one or more electrical traces, one or more wires, one or more nanowires, or
one or more electrically conductive ink structures formed in the second type of attachment patch ([0101] “the first to fourth electrodes or the third wiring electrode 831c of FIG. 12, or to mean including a wiring path (e.g., the second wiring electrode 831b in FIG. 12) connecting the first to fourth electrodes and the third wiring electrode 831c”).
Regarding claim 9, Lee teaches wherein the ECG device electromechanical interface and the common patch electromechanical interface are configured to cooperate to electromechanically couple the ECG device to an attachment patch of the first type and an attachment patch of the second type ([0093] “the coupling structure between a measurement module and an attachment pad (e.g., the module housing 301 and the attachment pad 302 in FIG. 3)” See Fig. 14 for the different pad’s for the first and second types. Examiner also notes the term “cooperate” as unclear claim language as that seemingly requires two objects to actively work together, mainly as humans. ).
Regarding claim 10, Lee teaches wherein:
each of the first type of attachment patch and the second type of attachment patch is configured to be electrically coupled to the ECG device through the common patch electromechanical interface and the ECG device electromechanical interface and to skin of a subject through the two first or two second patch electrodes ([0093] “the coupling structure between a measurement module and an attachment pad (e.g., the module housing 301 and the attachment pad 302 in FIG. 3)” See Fig. 14 for the different pad’s for the first and second types the can all fit the same measurement housing 301.);
the first type of attachment patch includes a non-arrythmia attachment patch (Fig. 14. Examiner notes that the patch can be any electrode patch that is capable of sensing the intended signal as the construction of the patch is not described and fails to include any circuitry to sense the specific signals and further fails to include any circuitry that limits its ability to sense other types of signals. Fig. 14 can be any type of patch making it non-arrhythmia.);
the second type of attachment patch includes an arrythmia attachment patch (Fig. 14. Examiner notes that the patch can be any electrode patch that is capable of sensing the intended signal as the construction of the patch is not described and fails to include any circuitry to sense the specific signals and further fails to include any circuitry that limits its ability to sense other types of signals. Fig. 14 can be any type of patch making it arrhythmia.);
each non-arrythmia attachment patch is configured to direct electrical signals from locations of the subject at which the two first patch electrodes are positioned when the non- arrythmia attachment patch is coupled to the skin of the subject to, respectively, the first and second electrodes of the ECG device ([0121] “According to certain embodiments, when the second adhesive layer 801c is attached to the user's body (skin), the third wiring electrode(s) 831c may be in direct contact with the user's body… a biological signal may be detected by the third wiring electrode(s) 831c and may be transmitted to a measurement module (e.g., the first to fourth electrodes 431a to 431d in FIG. 5)” Of the attachments of Fig. 14 electrodes 902/831c are coupled to the skin and direct signals to the measurement device.); and
each arrythmia attachment patch is configured to direct electrical signals from locations of the subject at which the two second patch electrodes are positioned when the arrythmia attachment patch is coupled to the skin of the subject to, respectively, the first and second electrodes of the ECG device ([0121] “According to certain embodiments, when the second adhesive layer 801c is attached to the user's body (skin), the third wiring electrode(s) 831c may be in direct contact with the user's body… a biological signal may be detected by the third wiring electrode(s) 831c and may be transmitted to a measurement module (e.g., the first to fourth electrodes 431a to 431d in FIG. 5)” Of the attachments of Fig. 14 electrodes 902/831c are coupled to the skin and direct signals to the measurement device.).
Claims 5 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US 20190239769)(Hereinafter Lee) in view of Bardy (US 20190167139) (Hereinafter Bardy).
Regarding claims 5 and 12, Lee teaches the inventions of claims 4 and 11. However, Lee does not teach the a spacing distance of the electrodes. Bardy, in a similar field of art, teaches an insertable cardiac monitor that has an implantable housing with electrodes (Abstract), and further teaches wherein:
the first spacing of the two first patch electrodes of the first type of attachment patch is about 35 millimeters (Claim 10 recites the spacing being between 20 to 200 mm which includes 35 mm.); and
the second spacing of the two second patch electrodes of the second type of attachment patch is about 85 millimeters (Claim 10 recites the spacing being between 20 to 200 mm which includes 85 mm.) to explore optimal configurations to acquire the P-wave ([0039]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the ECG system of Lee, with the electrode spacing of Bardy, because such a modification would allow to explore optimal configurations to acquire the P-wave.
Claims 12 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US 20190239769)(Hereinafter Lee) in view of Quinlan et al. (US 20160242654)(Hereinafter Quinlan) and Bardy (US 20190167139) (Hereinafter Bardy).
Regarding claims 12, Lee teaches the inventions of claims 4 and 11. However, Lee does not teach the spacing distance of the electrodes. Bardy, in a similar field of art, teaches an insertable cardiac monitor that has an implantable housing with electrodes (Abstract), and further teaches wherein:
the first spacing of the two first patch electrodes of the first type of attachment patch is about 35 millimeters (Claim 10 recites the spacing being between 20 to 200 mm which includes 35 mm.); and
the second spacing of the two second patch electrodes of the second type of attachment patch is about 85 millimeters (Claim 10 recites the spacing being between 20 to 200 mm which includes 85 mm.) to explore optimal configurations to acquire the P-wave ([0039]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the ECG system of Lee in view of Quinlan, with the electrode spacing of Bardy, because such a modification would allow to explore optimal configurations to acquire the P-wave.
Claims 11 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US 20190239769)(Hereinafter Lee).
Regarding claim 11, Lee teaches An electrocardiogram (ECG) system (Fig. 3 (300)), comprising:
an ECG device that includes a housing, an ECG sensor disposed in the housing, and first and second electrodes accessible from outside the housing and electrically coupled to the ECG sensor, wherein the housing and the first and second electrodes define an ECG device electromechanical interface (Fig. 8 (600 measurement module/ECG device, 601 housing, 631a-d electrodes accessible outside the housing) [0099] “an electronic device (e.g., a processor (e.g., processor 120 of FIG. 1) of the measurement module 600) may identify an input or request associated with an electrocardiogram [since ECG is collected via electrodes, it contains an ECG sensor] measurement of a living body”);
a first type of attachment patch that includes a common patch electromechanical interface that is complementary to the ECG device electromechanical interface and two first patch electrodes with a first spacing (Fig. 14 Pad of col. 4 row 2. See first patch electrodes 902 that are circles on the ending of each curve. The common patch electromechanical interface is 911a that contains the electrodes on the pad of Fig. 13 that attaches the ECG device to the pad. See the spacing between the electrodes visually in Fig. 14. [0124] “there may be various extension directions or lengths of the extension portions (e.g., the extension portions 811b in FIG. 13).”); and
a second type of attachment patch that includes the common patch electromechanical interface that is complementary to the ECG device electromechanical interface and two second patch electrodes with a second spacing that is greater than the first spacing (Fig. 14 Pad of col. 3 row 2. See second patch electrodes 902 that are circles on the ending of each curve. The common patch electromechanical interface is 911a that contains the electrodes on the pad of Fig. 13 that attaches the ECG device to the pad. The position of electrodes 902 between the second and first type pads can be visually seen as the distance between the electrodes 902 of col. row 2 is far greater than the spacing of col. 4 row 2),
wherein the first type of attachment patch further includes:
a backing material (Fig. 3(302));
two first electrode contacts partially embedded in the backing material and each having an exposed device-facing side at least partially aligned for electrical coupling to a corresponding one of the first and second electrodes of the ECG device ([0106] “As will be described later, the first to fourth terminals 731a to 731d [ECG device electrodes 431a-d are electrically coupled to 731a-d [0109]-[0110]] may be electrically connected to a first wiring electrode (e.g., the first wiring electrode 831a [first electrode contacts] in FIG. 12) disposed substantially in the pad body, or may be a part of the first wiring electrode.” The ECG device electrodes must be aligned with the electrode contacts for electrical coupling as the device cannot function without alignment, see Fig. 3.), wherein a first one of the two first patch electrodes and a first one of the two first electrode contacts is configured to at least partially align with the first electrode of the ECG device and a second one of the two first patch electrodes and a second one of the two first electrode contacts is configured to at least partially align with the second electrode of the ECG device (See Fig. 12 where device electrodes 831a are aligned with electrode traces 831, which are aligned with patch electrodes 831c. The alignment is a physical alignment with one another and an electrical alignment to be capable of collecting ECG. The first and second patch electrodes (831c), electrode contacts (831a), and electrode on the ECG devices (631a-d) overlap one another in the direction of the skin (thereby to both the substrate and the skin facing side of the first type of attachment patch/substrate) to be able to collect the ECG. This direction is simply the electrical connection between the skin to the ECG device electrode, via the patch electrodes and contact electrodes. It is further noted that the claim is not claiming a direct vertical, over the top, configuration of the 3 components. );
an adhesive layer on a device-facing side of the backing material, the adhesive layer included in the common patch electromechanical interface ([0111] “In another embodiment, the second adhesive member 721 may be provided on a first face of the pad body (e.g., the first face F1 in FIG. 13) rather than on the seating plate 711” Examiner notes that the claim recites that there is an adhesive layer on the backing material that is facing the device, and it is unclear how the adhesive layer is included in the common patch electromechanical interface. It is noted the claim does not limit the adhesive layer to be touching the common patch electromechanical interface, but only needs to be touch the pad/backing. See Fig. 13 where adhesive 821 takes shape of the common patch electromechanical interface of Fig. 7’s housing.), wherein the adhesive layer defines two first cutouts around the two first electrode contacts to avoid the adhesive layer interfering with an electrical connection between the two first electrode contacts of the first type of attachment patch and the first and second electrodes of the ECG device (See Fig. 9 (721) that show the adhesive that contains cutouts for the electrodes. See MPEP 2114(I) regarding functional language. Since the structure of an adhesive containing cutouts is taught, the functional language, of avoiding layer interference, is possessed in the structure. ).
Lee teaches different embodiments of the adhesive location ([0111]) and different types of attachment patches (Fig. 14). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to combine the embodiments of the adhesive location ([0111]) and different types of attachment patches (Fig. 14) of Lee because such a modification would to allow for the different uses of the pads for an improvement in the flexibility of the attachment pad (0125).
However, Lee does not teach the adhesive layer configured to be positioned between and in direct contact with the ECG device and the backing material. Nevertheless, the use of magnets (Fig. 6(535), [0110], and Fig. 9 (731a-d) or [0146]) is a functional equivalent to the adhesive layer for the coupling of the housing with the seating plate, the patch, and the coupling structure of the patch, which allows to increase utilization efficiency of space inside the measurement module (0092] and [0110] Examiner notes that Lee teaches that the use of magnets/magnetic force which is used to fix the attachment pad (patch) to the housing (0146]), similar to the fixing of the seated plate to the pad (patch) ([0110]) and therefore, an art recognized equivalence.). It would have been obvious to one having ordinary skill in the art at the time the invention was made to substitute the magnets for the adhesive layer, for the same functional equivalent purpose of coupling of the housing with the coupling structure of the patch, since it has been held to be within the general skill of a worker in the art to utilize efficiency of space inside the measurement module on the basis of its suitability for the intended use as a matter of obvious substitution. In reRuff, 256 F.2d 590, 118 USPQ 340. See MPEP 2144.06(II).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOUSSA M HADDAD whose telephone number is (571)272-6341. The examiner can normally be reached M-TH 8:00-6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOUSSA HADDAD/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
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